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Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension (NCT03022851)

This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).
  • Device: Occlutech AFR Device
    Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Age is ≥ 18
    • Patient consents to participation
    • Patient has had a successful ballon atrial septostomy (BAS)- procedure and is in a stable hemodynamic state
    • Conventional treatment options for the patient are exhausted according to ESC- (European Society of Cardiology) and AHA (American Heart Association) -guidelines.
    • Syncope due to acute Pulmonary Hypertension episodes
    • Other causes of syncope must have been actively excluded
    • Syncope or pre-syncope >2 last 3 months
    • PH (Pulmonary artery pressure (PAP) > 25 mmHg, or pulmonary vascular resistance of > 3 Wood Units)
    • Right heart failure, chronic and clinically severe
    • Severe pulmonary hypertension as evident by echocardiography or catheterisation
    Exclusion Criteria:
    • Local or generalized sepsis or other acute infection(s)
    • Thrombophilic coagulation disorder
    • Allergy to nickel and/or titanium and/or nickel/titanium-based materials
    • Allergy to anti-platelet, -coagulant, or -thrombotic therapy
    • Intolerance to contrast agents
    • Participation in other medical trials shorter than 30 days before the intended AFR implantation procedure
    • Pregnancy
    • Any intracardiac intervention within the last 30 days
    • Occluded inferior vena cava access
    • Previous ASD/PFO closure device in place
    • Intracardiac thrombus

    1 locations

    Germany (1)
    • Klinikum der Universität München
      Munich, Bavaria, Germany, 81377
    18 July, 2017
    13 August, 2017
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